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As the spread of the 2019 Coronavirus Disease (COVID-19) continues to grow globally, the FDA and other global ...
The interoperability of medical devices is an important factor to consider especially with the increase in the ...
In today’s modern era of the internet, it is a given that as medical device technology continues to develop, so ...
The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical ...
Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are ...
How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene ...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by ...
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, ...
An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical ...
Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of ...
Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified ...
The FDA released two final rules surrounding the classification, and the requirement to submit a pre-market ...
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